What will Dynamic DRUMBEAT^® for Pharmaceuticals help me accomplish?

Dynamic DRUMBEAT^® for Pharmaceuticals will help you accomplish the following:

• Link GMP-related SOPs and Policies to DRUMBEAT® concepts
• Inventory available GMP-related SOPs and Policies against applicable regulatory requirements
• Identify documents that meet your regulatory requirements
• Identify the required documents that are missing, and identify where they are missing
• Identify the exact regulatory language that relates to a specific document
• Analyze the quality of current documents using established quality attributes and metrics
• Prepare for audits and Pre-approval Inspections, and System Based Inspections
• Prepare for conversion to electronic document management
• Reinforce understanding of GMP regulations
• Conduct efficient and comprehensive quality assurance audits

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How do I link my SOPs to regulations using Dynamic DRUMBEAT^® for Pharmaceuticals?

By reviewing key terms in SOP titles, DRUMBEAT^® Concepts can be assigned to each GMP-required SOP. These DRUMBEAT^® Concepts have been linked by Drumbeat Dimensions, Inc. to various worldwide regulations, thus providing a seamless link between your SOPs and the regulations. Forms are provided in Dynamic DRUMBEAT^® for Pharmaceuticals (e.g., Form A) for listing your SOPs and indicating the relevant DRUMBEAT^® Concepts for each SOP. If you prefer you can indicate the DRUMBEAT^® Concepts on your own list of SOP titles, to save time. Once the DRUMBEAT^® Concepts are assigned, you can find the regulations associated with the DRUMBEAT^® Concept by locating the DRUMBEAT^® Concept in Dynamic DRUMBEAT^® for Pharmaceuticals and then clicking on the regulation of interest associated with the assigned DRUMBEAT^® Concepts.

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Why should I link my SOPs to DRUMBEAT^® Concepts?

Linking SOPs to DRUMBEAT^® Concepts allows you to perform a variety of tasks including, and not limited to the following:

• Conduct a Compliance Risk Analysis Profile (Gap Analysis) to determine which, if any, SOPs are missing
• Compare SOPs across multiple plant sites to reduce redundancies, and to find copies of missing SOPs that may be available at another site
• Sort and organize SOPs by DRUMBEAT^® Concepts so that related SOPs are grouped together, for ease in comparing and cross-referencing SOPs
  Prepare for audits
• Associate GMP Training with SOPs.

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How can I use Dynamic DRUMBEAT^® for Pharmaceuticals to prepare an audit plan?

Using DRUMBEAT^® Concepts simplifies preparation of an audit plan. After determining the scope of the audit, select the DRUMBEAT^® Concepts that are most relevant to the audit scope. If SOPs are already linked to the DRUMBEAT^® Concepts, locating the applicable SOPs is simplified. DRUMBEAT^® Quality Screening can be performed on the SOPs prior to the audit providing a quick preview of the quality of the SOPs. Also since the DRUMBEAT^® Concepts are linked to the regulations, the applicable regulatory requirements can be quickly located and reviewed.

Let the auditees see the plan ahead of time - they will then not only know what's coming, but they will be better prepared to help you address the issues efficiently. The DRUMBEAT^® format also makes it easier to the Audit Report.

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Why are SOPs so important?

Both Regulators and Industrialists recognize SOPs as the basic vehicle by which management conveys to workers how jobs are to be performed, especially with regard to ensuring product quality. Hence, written procedures are required by essentially all international regulations. SOPs help ensure that everyone is provided with the same set of instructions describing how a task is to be performed. DRUMBEAT^® Concepts help to indicate what SOPs are required by regulations.

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How can Dynamic DRUMBEAT^® for Pharmaceuticals help me improve my SOP quality?

Dynamic DRUMBEAT^® for Pharmaceuticals provides two levels of document quality determination, both of which can be based on the same fixed or customized list of quality attributes:

SOP Quality Screening is an efficient method for rapidly determining overall quality of numerous SOPs to help decide which need the highest priority attention. Quality Screening Results are semi-quantitative and are more subjective than those of DrumKEY™ Analyses. Quality Screening can be used by reviewers when reviewing a new or revised SOP to help avoid creating new SOPs with poor quality.

DrumKEY™ Analysis provides comprehensive insight into document quality; but can require up to an hour a page, even by a DRUMBEAT^® expert. Hence, the DrumKEY™ analysis is intended to be used sparingly, and strategically, as an audit tool. DrumKEY™ quality attributes provide extremely useful guidance for upgrading documents in need of repair.

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How can Dynamic DRUMBEAT^® for Pharmaceuticals help me convert to an Electronic Document Management System?

Linking SOPs to DRUMBEAT^® Concepts will point out redundant SOPs that can be eliminated prior to conversion to Electronic Document Management System, thus saving time. Performing a Quality Screening may indicate poor quality SOPs that should be revised before inclusion in the Electronic Document Management System database, thus ensuring that only necessary high quality SOPs are included. DRUMBEAT^® Concepts can also serve as useful document attributes in an Electronic Document Management System for numerous linking purposes.

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What happens when regulations change?

Drumbeat Dimensions, Inc. continuously reviews regulations to ensure that those used in Dynamic DRUMBEAT^® for Pharmaceuticals are kept current. Dynamic DRUMBEAT^® for Pharmaceuticals is updated promptly after the new regulations appear in final form. Resulting changes to DRUMBEAT^® Concepts are provided in updates to all clients under a maintenance contract, which is free for the first year after product purchase.

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Are FDA Guidance documents included in Dynamic DRUMBEAT^® for Pharmaceuticals?

Currently, Dynamic DRUMBEAT^® for Pharmaceuticals only contains FDA regulations that have been promulgated through due process and published in the CFR. Draft FDA Guideline Documents are often misleading. Finalized Guidelines from other countries are included when they are treated as regulations. Finalized FDA Guidance Documents that become "de facto law" will usually be included.

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How can I use Dynamic DRUMBEAT^® for Pharmaceuticals for GMP Training?

When Dynamic DRUMBEAT^® for Pharmaceuticals is used to link SOPs to DRUMBEAT^® Concepts (and therefore to regulations), GMP Training lessons can be easily prepared that include both relevant GMP regulatory requirements and actual SOPs. Likewise, necessary job function training can be more clearly defined by using DRUMBEAT^® Concepts to relate specific SOPs with the regulations required.

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Do you still have questions about Dynamic DRUMBEAT^® for Pharmaceuticals?

Send your questions to Drumbeat Dimensions, Inc. using our Contact and Comments form for possible inclusion on the Dynamic DRUMBEAT^® for Pharmaceuticals FAQ page.